Subjective effects of tizanidine (DS103-282), a centrally acting muscle relaxant in healthy volunteers. Double blind comparative study vs. diazepam and placebo.:Double Blind Comparative Study vs. Diazepam and Placebo

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Since an experiment in monkeys showed that tizanidine, a centrally-acting muscle relaxant, has a certain amount of reinforcing capacity, a double blind comparative study using questionares was carried out in 12 healthy volunteers to investigate subjective effects of the drug as a measure of psychic dependence potential using diazepam and placebo. The dosages of tizanidine were 3 mg and 6 mg and that of diazepam was 10 mg. As the result, neither the maximal clinical dosage of tizanidine (3 mg) nor twice that dosage (6 mg) induced any marked somatic or psychic symptoms compared with placebo. On the other hand, 10mg diazepam induced symptoms at a significantly higher incidence than placebo and tizanidine; i. e., many of those given diazepam mentioned experiencing such central suppression symptoms as drowsiness and absent-mindedness. Further, they gave positive answers to some items which are regarded as one of direct parameters of psychic dependence; e. g., one noted that the subjective effects of the drug was " desirable ", two indicated a " euphoric feeling" and five noted a " drunken feeling ". Influence on tapping, blood pressure, etc. were observed in the 6 mg tizanidine group in the same manner as in the diazepam group.The blood concentration of 6 mg tizanidine was about four times as high as 3 mg tizanidine. These results suggest that tizanidine is very unlikely to have psychic dependence potential because of a lack of observable subjective effects.
一般社団法人日本臨床薬理学会の論文

Subjective effects of tizanidine (DS103-282), a centrally acting muscle relaxant in healthy volunteers. Double blind comparative study vs. diazepam and placebo.:Double Blind Comparative Study vs. Diazepam and Placebo

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